Change Control Specialist

Thoratec  Switzerland GmbH is part of Abbott Laboratories, one of the world’s leading companies in medical devices and healthcare. We are the global market leader for implantable and extracorporeal blood pump systems based on magnetic bearings. Our lifesaving medical devices, which are developed and produced on-site in Zurich, are used for the short- and long-term treatment of patients suffering from severe heart disease. 

Our Zurich site employs approximately 150 people, covering areas including R&D and manufacturing. Currently, we are expanding our innovative and high-caliber team in Zurich and an exciting opportunity exists for a motivated and talented software engineer. 

Change Control Specialist - Medical Device 

As part of the process engineering team you will support the team in creating, editing and managing the documentation regarding manufacturing processes, part specifications, inspection procedures and the design. You will help the manufacturing team to ensure that the product and project documents are properly managed and traced and approved by the management and all changes to the product or process are correctly reflected in all modified documentation. This position does not requires per se a strong technical background, but good understanding of MedTech/Pharma environment, good communication skills and an independent problem-solving mindset. 

 Main Activities 

• Create, edit, manage and modify all product and process documentation using PLM and ERP software packages. 

• Be a part of the process engineering team with extensive interactions with the R&D and Quality departments. 

• Ensure traceability and compliance of the documents with the Quality templates and instructions as well as global regulatory requirements. 

 Qualifications 

• Technical degrees in Technical/scientific fields.

• 3 to 6 years of experience in Engineering, Quality or Technical Writing at a manufacturing environment. 

• Experience with medical device manufacturing of electro-mechanical equipment. 

• Good written and oral English communication skills. German speaking an advantage. 

• Previous experience with some PLM and ERP software packages ideally with Windchill and SAP. 

• Familiarity with IT data services and regulated document authentications and safeguards. 

What We Offer 

• A challenging position in a fast-growing crisis independent industry 

• To become part of a young, dynamic, highly educated, highly skilled, and motivated team 

• Flat hierarchies, open appreciative mentality, and efficient, constructive lines of communication 

• Multi-national environment, where we foster the development of our talents within the enterprise 

• Competitive compensations and benefits 

• A workplace in the centre of Zurich with R&D and manufacturing under one roof 

Looking forward to receiving your application documents including CV, motivation letter, and job certificates in PDF format.